Last updated: July 23, 2023
Sponsor: Wang Mo
Overall Status: Active - Recruiting
Phase
4
Condition
Dermatomyositis (Connective Tissue Disease)
Glomerulonephritis
Collagen Vascular Diseases
Treatment
GlucoCorticoid
Clinical Study ID
NCT05969522
ANCA20230706
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Newly diagnosed AAGN patients with onset age of 5-17 years, complete renal biopsyand regular follow-up in the hospital; 2) All enrolled children met the followinginclusion criteria: ANCA classification criteria: Patients who meet the 2007 EuropeanMedicines Agency (EMA) classification algorithm or the 2012 CHCC definition. Clinicalclassification includes: micropolyvasculitis (MPA), granulomatous polyvasculitis (GPA)and eosinophilic granulomatous polyvasculitis (EGPA); AAGN diagnostic criteria: ANCA vasculitis combined with any of the following:
- Hematuria: gross hematuria or microscopic hematuria: 3 times microscopic hematuriawithin 1 week: red blood cells > in urine routine; 3 / high magnification field (HP)or > 17 /ul (higher than normal value, can be adjusted according to the standard ofthe laboratory of each center);
- proteinuria: meet any of the following: ① 3 times in 1 week urine routine proteinpositive; 2) 24h urinary protein quantification > 150 mg or urinaryprotein/creatinine (mg/mg)> 0.2; 3 urinary microalbumin higher than normal for 3times in 1 week;
- Renal insufficiency: increased serum creatinine > 10% base or decreased creatinineclearance > 25%.
Exclusion
Exclusion Criteria:
- Patients who relied on dialysis for more than 1 month at the time of diagnosis, or theproportion of glomerular sclerosis ≥75% at the time of renal biopsy; 2) Patients withsevere infection (such as diffuse peritonitis, severe pneumonia, cellulitis, activeEpstein-Barr virus infection, active cytomegalovirus infection, hepatitis B virusinfection, tuberculosis infection, fungal infection, etc.) and tumor.
- Patients with other primary or secondary kidney diseases (such as IgA nephropathy,membranous nephropathy, anti-glomerular basement membrane nephritis, polycystic kidneydisease, renal dysplasia, urinary tract malformation, etc.); 4) Parents or children refusedto join the group.
Study Design
Total Participants: 200
Treatment Group(s): 1
Primary Treatment: GlucoCorticoid
Phase: 4
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025
Connect with a study center
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing 400015
ChinaActive - Recruiting

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